MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / VORTEX; PORT & CATHETER, IMPLANTED

Catalog Number	H787P5455K0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the vortex port product family and the failure mode "catheter fractured." no adverse trend was identified.Returned for evaluation was one vortex port with catheter tubing.As reviewed, the port catheter tubing was fractured between the 10 and 11 cm mark and sliced between the 11 and 12 cm mark.The blue boot was attached to the port stem with the catheter extending out 9 cm.The catheter was connected to the port at the 20 cm mark, and it appeared to have been trimmed to 20 cm.At the catheter fracture site it appeared squashed and oval like it was pinched off.The catheter was measured (id and od) and found to be within specification.The reported complaint description is confirmed for catheter tubing fracture between the 10 and 11 cm mark.Although no definite root cause could be identified, the catheter broke about 9 cm away from the port.The oval/crushed appearance of the fracture suggests it was a pinched, flex failure.The rest of the catheter was found to be normal in appearance and measured within specification.Based on the location of the fracture from the port body and the fracture appearance, the likely root cause of the failure is "pinch-off" syndrome.Angiodynamics' incoming inspection for the catheter tubing include visual inspection for damage or defects, untimate tensile force verification and od/id verification.The directions for use provided with the port contain reference to the potential complication of pinch-off-syndrome including guidance on port placement to avoid this condition and symptoms after placement which could indicate pinch-off-syndrome.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), the catheter portion of a vortex port, ruptured and had to be removed.Patient condition was reported as "stable." the used device was returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6959503
• Report Number: 1056436-2017-00108
• Device Sequence Number: 683244
• Product Code: LJT
• UDI-Device Identifier: H787P5455K0
• UDI-Public: H787P5455K0
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: H787P5455K0
• Device Lot Number: 5126897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR